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Recruiting NCT07726082

Micro-choice-based Intervention for Multicausal Fatigue

No phase Interventional Multicausal Fatigue Fatigue Post COVID Condition Long COVID Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Micro-choice-based intervention.
Who it may be relevant to
Registry conditions: Multicausal Fatigue, Fatigue, Post COVID Condition, Long COVID Syndrome. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Micro-choice-based Intervention for Multicausal Fatigue: Proof of Concept Study

Overview

This proof-of-concept study aims to evaluate the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.

Detailed description

The intervention of this study includes a preparation phase, a four-day intensive group treatment, and a follow-up phase to support the integration of new behaviors into daily life. As no comparable program currently exists in Switzerland, this project addresses a significant gap in care. If found to be feasible, the intervention has the potential to improve quality of life, support reintegration into daily and professional activities, and reduce the risk of disability and long-term work incapacity, thereby also contributing to lower healthcare costs.

Interventions

  • Behavioral Micro-choice-based intervention
    The intervention consists of three phases: (1) a preparation phase including a preparatory webinar about the concept of micro-choices; active decision to participate; (2) a concentrated four-day group intervention based on the micro-choice model, delivered by an interdisciplinary team (psychosomatics, internal medicine, physiotherapy, occupational therapy); and (3) a follow-up phase over three weeks, during which participants are supported in integrating behavioral changes into everyday life thr

Primary outcome measures

  • Retention rate [Time frame: up to 6 month]
Secondary outcome measures (10)
  • Patient satisfaction [Time frame: up to 6 month]
  • Fatigue [Time frame: up to 6 month]
  • Somatic Symptom Severity [Time frame: up to 6 month]
  • Somatic Distress [Time frame: up to 6 month]
  • Depressive Symptoms [Time frame: up to 6 month]
  • Anxiety Symptoms [Time frame: up to 6 month]
  • Functional capacity [Time frame: up to 6 month]
  • Change in Quality of life [Time frame: up to 6 month]
  • Work ability [Time frame: up to 6 month]
  • Work and Social Adjustment [Time frame: up to 6 months]

Eligibility criteria

Inclusion criteria

\- Experiencing persistent fatigue with a significant impact on daily functioning (Chalder Fatigue- Scale bimodal ≥ 4)

Exclusion criteria

  • Have insufficient proficiency in German to complete study-related questionnaires
  • Lack the cognitive capacity to understand study procedures (e.g. due to dementia)
  • Present with severe medical conditions that may interfere with participation (e.g., advanced organ failure, uncontrolled inflammatory or autoimmune diseases, or severe psychiatric disorders)
  • Have active cancer or are currently undergoing cancer treatment
  • Are deemed incompatible with group participation during the preparation phase, based on a team assessment. Reasons for exclusion based on group incompatibility include:
  • Need for a level of individual therapeutic support that exceeds what can be provided in a group setting; b) Refusal to engage in group-based therapy; c) Personality traits that are considered incompatible with group dynamics; d) Failure to attend the mandatory preparatory webinar (no-show is considered a no-go); e) Other significant reasons as determined by the therapeutic team)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • University Hospital Basel — Basel

Identifiers

NCT: NCT07726082 · 2025-01861; th25meinlschmidt2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗